According to homeopathic principles, the active ingredients in this product temporarily relieve earache symptoms such as: • sensation of fullness of the ear • sensitivity to cold, drafts, and water • the annoyance of water-clogged ears by helping clear water trapped in the ear
FOR USE IN THE EAR ONLY. For children ages 2 and over: • Remove tamper-evident seal from neck of bottle. • Twist cap off bottle. • Tilt child’s head sideways. • DON'T squeeze bottle, squeeze plastic tip to release 3-5 drops into ear (tip of applicator should not enter ear canal). • Keep drops in ear for 3-5 minutes by keeping head tilted or placing cotton in ear. Any excess drops can be wiped away from outer ear. ...
www.SimilasanUSA.comDrug Facts – Children’s Earache Relief
Chamomilla 10X
Mercurius solubilis 15X
Pulsatilla 12X
Sulphur 12X
sensitivity to drafts, soothing
fullness, sensitivity to cold
night time calmative
itchiness, sensitivity to water
According to homeopathic principles, the active ingredients in this product temporarily relieve earache symptoms such as:
• sensation of fullness of the ear
• sensitivity to cold, drafts, and water
• the annoyance of water-clogged ears by helping clear water trapped in the ear
• Do not use in the eyes.
Children under 2 years of age should be seen by a physician.
• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
ask a health professional before use.
If swallowed, get medical help or contact a Poison Control Center right away.
• symptoms persist for more than 48 hours
• there is discharge from the ear
• there is a fever of 102°F or greater
• ear drainage or discharge
• pain, irritation, or rash in the ear
• had ear surgery
• dizziness
FOR USE IN THE EAR ONLY.
For children ages 2 and over:
• Remove tamper-evident seal from neck of bottle.
• Twist cap off bottle.
• Tilt child’s head sideways.
• DON'T squeeze bottle, squeeze plastic tip to release 3-5 drops into ear (tip of applicator should not enter ear canal).
• Keep drops in ear for 3-5 minutes by keeping head tilted or placing cotton in ear. Any excess drops can be wiped away from outer ear.
• Use up to 4 times daily for no more than 48 hours, or as directed by a doctor.
Active ingredients are manufactured according to homeopathic principles.
Purified water, Vegetable glycerin
Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com
Similasan
Children’s
Earache
Relief
EAR DROPS
10 ml / 0.33 fl oz
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53799-276-11 | 2023-01-30 | C162847 | 48780-1 | f386c649-a118-0266-e053-dadaa90a7c1a | Childrens Earache Relief |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53799-276-11 | Childrens Earache Relief | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 53799-276 | 53799-276-11 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CHAMOMILE | FGL3685T2X | ACTIB |
| MERCURIUS SOLUBILIS | 324Y4038G2 | ACTIB |
| PULSATILLA PATENS WHOLE | 4M1169RWJD | ACTIB |
| SULFUR | 70FD1KFU70 | ACTIB |
| Glycerin | PDC6A3C0OX | IACT |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 5e1efbd7-706a-4393-95bc-3a122f1241ca | d6581b42-45d2-4b25-a902-85e952d08b49 | 2021-04-22 | Warnings | 5e1efbd7-706a-4393-95bc-3a122f1241ca d6581b42-45d2-4b25-a902-85e952d08b49 |
Adverse event summaries are temporarily unavailable. Other product information remains available.